Mainz Biomed Provides First Quarter 2025 Corporate Update and Path to FDA Premarket Approval
BERKELEY, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first quarter of 2025, and provided an outlook on its path to FDA premarket approval.
During the first quarter of 2025:
- Path to FDA premarket approval: The Company enrolled the first patient into its feasibility study eAArly DETECT 2, which evaluates the Mainz Biomed's next-generation colorectal cancer (CRC) test, integrating a portfolio of proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test. The study is expected to include a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to prevention. The inclusion of the first patient keeps the Company on schedule to report top-line results by the end of 2025.
- Mainz Biomed signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity.
- The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based CRC screening test to the Swiss market for the very first time, marking Mainz Biomed's initial footprint in Switzerland. In Switzerland, thousands of new cases are diagnosed annually, underscoring the urgent need for early detection and prevention. The introduction of a DNA-based CRC screening test offers a transformative opportunity to increase participation rates and ensure early detection, aligning with national efforts to reduce CRC-related mortality and improve population health outcomes.
- Mainz Biomed announced that GANZIMMUN Diagnostics has officially launched the enhanced ColoAlert CRC screening test. Since January 2025, patients across Germany can access this new version of the Company's screening test. The announcement was made in conjunction with Colorectal Cancer Awareness Month in March.
- On January 23, 2025, the Company received formal notice from Nasdaq confirming that it had regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now in full compliance with all Nasdaq continued listing requirements.
"I'm extremely pleased with the progress achieved during the first quarter of 2025 as we execute our strategy driven by our excellent clinical results in three studies published during 2024," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "Our eAArly DETECT 2 study, scheduled to report results by the end of 2025, is essential to move rapidly to the beginning of enrollment for our pivotal U.S. FDA study ReconAAsense shortly thereafter."
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a development study to finalize with the next gen CRC screening test as preparation for the pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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Forward-Looking Statements
Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; and (iii) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the "SEC") by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
